Meningitis outbreak: Pharmacy bill with loophole in House

Apr. 8, 2013

Dr. David Reagan

Written by

Tom Wilemon and Walter F. Roche Jr.

The Tennessean

A bill that would create a loophole so compounding pharmacies from all states could bypass patient-specific prescription requirements during drug shortages does not have the blessing of the Tennessee Department of Health, but it does contain two amendments from the agency.

Dr. David Reagan, the state’s chief medical officer, said the agency recognizes the difficulty of balancing measures to prevent another fungal meningitis outbreak with efforts to ease drug shortages. The bill, which would allow health care providers to obtain compounded drugs without having to identify a patient in cases where a product “is not commercially available,” easily passed the Senate last week. The House has yet to schedule a vote.

“You’ve got competing priorities here,” Reagan said. “You have an unprecedented number of drug shortages in this country and in this state. It is really difficult to understand how pervasive this has become. It is a real need and a real issue that is occurring at the same time as this other real need and issue about the sterility and safety of these compounded products.”

The agency neither endorses nor opposes the bill, he said.

Terri Lewis, a Tennessee-based patient advocate, is worried about the bill becoming law.

“The current proposal before the Tennessee legislature attacks the economic problem of supply and demand by institutionalizing the wrong solution,” Lewis said. “It is wrongheaded at every level.”

Massachusetts-based New England Compounding Center made the medicine linked to the fungal meningitis outbreak that was discovered in Nashville last year. The company shipped large quantities of a contaminated drug without patient-specific prescriptions, which was a violation of its operating license, and it failed to maintain sterility safeguards, according to government regulators.

FDA calls safeguard an important one

The patient-specific requirement is considered an important safeguard, according to a letter the U.S. Food and Drug Administration sent this year to a drug compounder. Illinois-based PharMEDium Services had sought to link patients to compounded drugs after shipment. The FDA in 2005 had allowed the company to use a bar code method in a pilot program.

“It does not appear that PharMEDium has consistently implemented and maintained the conditions under which we were willing to exercise enforcement discretion — linking each of the firm’s compounded drugs to specific patients who received them,” the FDA letter stated. “During a September 2007 inspection of the PharMEDium Sugar Land, Texas, facility, firm management said it was the responsibility of the hospitals receiving the drugs to link them to patients and that PharMEDium did not conduct surveillance of the hospitals to determine whether this was done.”

The FDA went on to point out that two months later, medicine made at the company’s Cleveland, Miss., compounding lab was suspected of being the source of bacterial infections at hospitals in Maryland and California. But neither hospital was able to determine which lot of medicine the patients had received, the letter said.

“Whether a firm obtains patient-specific prescriptions is one of the factors that FDA considers in evaluating whether the firm is engaged in traditional pharmacy compounding versus manufacturing in the guise of compounding,” the letter said.

The two amendments to the Tennessee drug compounding bill suggested by the state health department are additional safeguards, Reagan said. The amendments require inspection surveys current within a year, the reporting of any disciplinary action within two weeks, reports to track the volume of medicine produced, and compliance with the guidelines set by U.S. Pharmacopeia, a national standard-setting organization for pharmaceuticals.